Interstitial Assessment of Architectural Heterogeneity in Prostate Cancer Using a Fine Needle Photoacoustic Probe

NCT05965180 | Recruiting FDA Device

• 3 other identifiers: UMCC 2022.015HUM00217834R37CA222829
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

In this project, we will integrate the Photoacoustic (PA) technology into a prostate biopsy procedure through a fine needle probe. The needle probe will be in the shape of a biopsy needle and compatible with the needle insertion mechanism in the transrectal ultrasound (TRUS) probe. When inserted into the prostate, the fine needle PA probe will assess the histological information in its surrounding tissue without any tissue extraction. The needle probe has been tested in prostate tissue samples and whole human prostates ex vivo.

Conditions

Prostate Cancer

Keywords

Biopsy

Outcome Measures

Primary Outcomes (1)

• Demonstration of reliable measurements

  The primary aim of this study is to demonstrate that our fine needle PA probe can acquire reliable measurements of prostate glands. This will be indicated by a signal-to-noise ratio of the measurements that is larger than one. We will calculate the signal to noise ratio of the signals as the peak-to-peak signal magnitude over the amplitude of the system background signal. The technical failure is that we will not be able to achieve measurements with signal-to-noise ratios larger than 1 in 10% of the measurements. We will have a futility analysis after first 5 patients are completed (thus 10 measurements). If of those 10 measurements, 2 have a SNR less 1, then the study will be stopped as it is unlikely to meet its 90% target.

  day 1

Secondary Outcomes (1)

• Determining the ability to observe differences between benign and cancerous regions

  day 1

Study Arms (1)

Biopsy

Patients will be identified once prostate biopsies have been scheduled. Once enrolled on trial, patients will undergo standard biopsy procedure as per clinical care. During this biopsy, research measurements will be completed using the fine needle photoacoustic probe.

Device: Fine Needle Photoacoustic Probe

Interventions

Fine Needle Photoacoustic Probe DEVICE

Fine Needle Photoacoustic Probe guided by the standard biopsy system without tissue core extraction

Biopsy

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with planned prostate biopsy procedures will be recruited through U-M Urology Clinics

You may qualify if:

• \) Planned prostate biopsy as part of routine clinical care
• \) \> 40 and \<80 years old

You may not qualify if:

• \) Known history of bleeding disorders or
• \) Patients taking anticoagulants, no matter doses or washout time
• \) Known allergy to silicone material
• \) Unable to provide informed consent
• \) Either the surgeon or the patient do not think the patient will not be able to complete all parts of the study, the patient will be excluded
• \) Involved in other investigational studies.

Sponsors & Collaborators

• University of Michigan Rogel Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

University of Michigan Rogel Cancer Center

Ann Arbor, Michigan, 48109, United States

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Guan Xu, Phd

  University of Michigan

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cancer AnswerLine

CONTACT

1-800-865-1125; CancerAnswerLine@med.umich.edu

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 27, 2023
• First Posted: July 28, 2023
• Study Start: October 16, 2023
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: November 24, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)